Industry News and Products

TYRX Presents Early Clinical Results from AIGISRX™ Antibacterial Envelope Retrospective Registry

TYRX, Inc. announced the initial, interim clinical results from its AIGISRX™ Antibacterial Envelope Retrospective Registry. AIGIS is an anti-bacterial mesh envelope developed to deliver anti-microbial agents that help provide protection against infections associated with implanted pacemakers and cardioverter defibrillators. AIGIS also securely holds a pacemaker (PM) or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body. During the Heart Rhythm Society 2009 Annual Scientific Sessions*, TYRX held an AIGIS Retrospective Registry (ARR) Investigator's Meeting, at which the study's early results were presented and discussed. The intent of the IRB-sanctioned, multi-centered, retrospective study is to define the implant success rate and incidence of infection, in patients implanted with cardiac rhythm management device (CRMD) and the AIGIS. To date, 393 patients from seven clinical sites have been enrolled in the study with a 98% success rate of CRMD implantation, with the 2% of failures not being AIGIS related. Of the 393 patients enrolled, at least one follow-up visit has been completed for 254 patients with a mean follow-up period of 59 days and a median follow-up of 32 days. Noting that De Oliveira et al1 report the median time to CRMD infection as 14 days, and Klug et al2 reported a median time to infection of 52 days, the preliminary infection rates in the ARR are as follows: Dr. Dan Lerner, TYRX's Chief Medical Officer, noted that “when one looks at the characteristics of the patients enrolled in the AIGIS Retrospective Registry to date, it is noteworthy that there is a high percentage of patients who are, according to published studies, at high risk of CRMD-related infections.” Dr. Dan Lerner continued, “Of the three generator pocket infections reported to date, two occurred in patients who had prior explants for infection within the past six months. Importantly, these early data indicate AIGIS does not interfere with CRMD implant success. The AIGIS Retrospective Registry continues with the expectation that, with the enrollment of three additional clinical sites, TYRX will collect data on over 500 AIGIS patients, representing more than 15% of the 3,000 AIGIS implanted to date. The company plans to continue the AIGIS Retrospective Registry follow-up period, which will provide clinicians greater insight into the clinical utility of AIGIS.” “We are delighted these data indicate clinicians are using AIGIS in the full spectrum of CRMD implant procedures. In particular, it is gratifying to see that AIGIS is being used in patients who are at very high risk for CRMD infection,” added Bill Edelman, CEO of TYRX, Inc. “In addition to the AIGIS Retrospective Registry, we have begun the process of recruiting approximately 20 clinical sites for the AIGIS Prospective Registry, which will follow AIGIS patients for 12 months and compare the incidence of infection to published historical and case-matched controls of cardiac rhythm management device recipients.” • This program was not part of the Heart Rhythm 2009 Official Scientific Sessions as planned by the HRS Scientific Sessions Committee. 1 de Oliveira et al, Circulation 2009;2:29. 2 Klug et al, Circulation 2007;116:1349. _____________________________

Endosense Receives CE Mark for TactiCath® Force-Sensing Ablation Catheter

Endosense has announced that it has received the CE mark for its TactiCath system. The first force-sensing ablation catheter developed worldwide, TactiCath gives physicians a real-time, objective measure of contact force during the catheter ablation procedure. The CE mark allows physicians across Europe to use TactiCath in the treatment of supraventricular tachycardia (SVT) of the right atrium. “The CE mark for TactiCath opens new horizons for Endosense, as we are establishing a new standard in the catheter ablation treatment of cardiac arrhythmias,” said Eric Le Royer, president and chief executive officer of Endosense. “With its unique ability to measure contact force, we expect the TactiCath to have a major positive impact on the safety and efficacy of catheter ablation, while also standardizing the ablation techniques and decreasing the learning curve.” The CE mark for TactiCath was granted based on select data submitted from Endosense’s TOCCATA (TOuCh+ for CATheter Ablation) clinical study, which was performed by 17 very experienced investigators at eight European centers. During procedures on 42 enrolled SVT patients, the device was found to cause no serious adverse events, and the primary study endpoint was reached. “The availability of the TactiCath marks an important advance in the field of catheter ablation,” said Karl-Heinz Kuck, MD, PhD (Asklepios Klinik St. Georg, Hamburg, Germany), Endosense European Scientific Advisor and primary investigator of the TOCCATA trial. “The TactiCath is a critically important addition to our treatment armamentarium, as it will help to prevent perforation and identify sites of low contact force which may lead to re-conduction from the pulmonary veins in patients undergoing atrial fibrillation ablation.” Endosense plans to release the TactiCath system in Europe in the second half of 2009. _____________________________

Data Shows Laser Assisted Lead Removal Effective: Spectranetics Releases Data from LExICon Study

97.7% Clinical Success Rate in Removal Procedures Demonstrated Spectranetics Corporation announced initial data from the four-year, retrospective LExICon (Lead Extraction in Contemporary Settings) study demonstrating the safety and efficacy of laser assisted lead removal using the Spectranetics laser sheath (SLS® II). Released by the HeartRhythm Journal in an online abstract entitled, “The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions,” the study examined laser assisted lead removal of 2,405 leads in 1,449 patients at 13 centers between January 2004 and December 2007. Resulting key data points include: • 97.7% clinical success rate • 96.5% complete lead removal success rate • 1.4% major adverse event rate — a 26% relative reduction* • 0.27% procedural mortality rate — more than a 50% relative reduction* * compared to a previous multi-center study evaluating the original laser sheath (SLS) “As an increasing number of patients receive implanted cardiac devices, understanding lead management options is critical,” said Dr. Bruce Wilkoff, principal investigator of the study, and Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic. “Patients are living longer, but leads don’t last forever. Transvenous lead extraction, when done by experienced operators, can be the best way to manage device infections, veins with blockages or lead malfunctions. The LExICon study shows the benefits and safety of laser sheath use by experienced physicians to assist with lead removal. Throughout the last decade, technology and technique have been refined, which is reflected in the high success rates and low complication rates demonstrated in this study.” In the LExICon study, 43% of procedures performed were for non-infection indications such as mechanical lead failure, upgrade of device system and abandoned leads. Concerns surrounding issues such as these have created increased awareness of the potential benefits of lead removal. “The former standard-of-care practice of abandoning leads is no longer acceptable for many patients given the knowledge of potential problems and the proven efficacy of lead removal procedures in experienced hands,” said Dr. Laurence Epstein, LExICon investigator, and Chief of Cardiac Arrhythmia Services at Brigham and Women’s Hospital. “This is an important topic of discussion among the medical community. While every patient situation is unique and must be evaluated individually, establishing guidelines that reflect the technologies available to assist removal procedures and benefits of experienced physicians is a necessary step to ensuring the highest-quality patient care.” _____________________________

BIOTRONIK Begins Pivotal Phase of IMPACT Study

Study Investigates Use of Remote Monitoring to Reduce Risk of Strokes in Patients with Atrial Fibrillation BIOTRONIK, Inc. announced completion of the first enrollment in the pivotal phase of its IMPACT clinical study. The IMPACT study is an international clinical trial that investigates whether the risk of stroke can be reduced in patients being treated for atrial fibrillation with cardiac devices through early detection of these arrhythmias using BIOTRONIK’s remote monitoring technologies, in conjunction with BIOTRONIK’s Lumax HF-T and DR-T defibrillators and a predefined anticoagulation plan. The state-of-the-art Lumax devices are equipped with BIOTRONIK Home Monitoring®, which provides the physicians with automatic, remote updates on their patients’ cardiovascular and device status. The IMPACT study began in 2008 with the technical feasibility phase, which included 227 patients and 27 sites. The pivotal phase, the next stage of the study, will include up to 100 sites and 2,700 patients randomized to the study. Movement of the IMPACT study into the pivotal phase demonstrates the technical feasibility and sound logistical design of the study, and that the defined markers of success in the roll-out phase have been met. It also affirms that the study’s steering committee and data safety monitoring board, both comprised of independent physicians, have validated the success of the original study design. "IMPACT is a unique study,” said Albert L. Waldo, MD, professor of medicine and professor of biomedical engineering at Case Western Reserve University in Cleveland, Ohio. “By using BIOTRONIK Home Monitoring capabilities, the medical community has the potential to change how we administer anticoagulants in patients with atrial tachycardia, who are at risk for stroke." Dr. Waldo is a member of the IMPACT Steering Committee. “Through the IMPACT study, we hope to gain insight for optimal treatment of patients with atrial fibrillation and heart failure,” said John J. Ip, MD, electrophysiologist at the Thoracic and Cardiovascular Health Care Foundation in East Lansing, Michigan, and IMPACT Steering Committee co-chairman. “By using device data with the BIOTRONIK Home Monitoring system, it may be possible to record and interpret the timing of atrial fibrillation and efficacy of early anticoagulation therapy in an aging population.” BIOTRONIK is currently supporting six other large-scale clinical trials in addition to the IMPACT study: EchoCRT, CLEAR, REPLACE, GALAXY, CELESTIAL and TRUST. _____________________________

St. Jude Medical Announces European Approval of Accent RF and Anthem RF Pacemakers Equipped With Wireless Technology

St. Jude Medical, Inc. announced European CE Mark approval of its Accent™ RF pacemaker and Anthem™ RF CRT-P (cardiac resynchronization therapy pacemaker). The Accent and Anthem product family features RF telemetry that enables secure, wireless communication between the implanted device and the programmer used by the clinician, making it the first integrated system of pacing devices with wireless telemetry from implant through follow-up. Wireless communication is used when clinicians implant the device and during follow-up appointments, which can be performed in the office or via remote monitoring with the patient at home, allowing for more efficient and convenient care and device management. Eric S. Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division, said “We designed the pacemakers in response to the physician and patient needs for intelligent products that streamline testing and follow-up, as well as to facilitate an exchange of information between the physician and patient. Using the remote monitoring capabilities, physicians will be able to stay abreast of device function and the patient’s condition, enabling a more timely response to the patient’s evolving needs.” The remote monitoring capabilities facilitated by the Accent RF and Anthem RF device product line will permit automated follow-up, and daily device safety checks with no patient action required. In addition to giving physicians fast access to device performance data, the wireless monitoring system will also allow physicians to compile a more complete patient record by easily transferring cardiac device data into electronic health records (EHRs). “Device implants and follow-ups are performed more quickly and easily with the wireless technology available in these devices,” said Johannes Sperzel, MD, from Kerckhoff Klinik in Bad Nauheim, Germany. To better assist physicians in accurately diagnosing and managing patients with fast rates in the heart’s upper chambers, the devices will also include a new AT/AF Alert feature. This feature is designed to notify physicians when a rapid atrial rate (atrial tachycardia/atrial fibrillation [AT/AF]) exceeds a programmed value or occurs over an extended time period. The devices also can be programmed to notify the patient of AT/AF episodes, as well as device- and lead-related issues, through a two-tone audible alert. In addition, the patient’s clinic can be informed through the home monitoring system. These features will allow the physician to more proactively manage patients’ atrial arrhythmias, such as AF, with appropriate medication or ablation. “The wireless communication automates patient home monitoring, as no patient interaction is required for data transmission. Diagnostic data and alerts can be transmitted automatically to the clinic, providing me with more timely notification of clinical events and better patient care,” said Professor Karlheinz Seidl, MD, from Klinikum der Stadt Ludwigshafen, in Ludwigshafen, Germany. In addition, the Anthem RF CRT-P and Accent RF pacemaker include advanced automatic features that help to promote patient safety and efficiency for the clinician. The devices can be programmed to automatically monitor and adjust the level of electrical energy needed for stimulating the patient’s heart, in the chambers where therapy is delivered; this includes up to three chambers for cardiac resynchronization therapy. The devices do this by measuring the heart’s reaction to electrical stimulation from the device and confirming that the heart is responding to the stimulation. This AutoCapture™ Pacing System feature provides the dual benefit of added safety for the patient and increased efficiency for physicians, as vital threshold tests are performed automatically and results are available to the physician for review on-demand during follow-up via a simple device interrogation. The launch of the Accent RF and Anthem RF devices marks the first time that these automatic test results can be accessed remotely or wirelessly in a clinic for a complete pacemaker family, including a CRT-P, and single- and dual-chamber models. The devices are also equipped with the St. Jude Medical QuickOpt® Timing Cycle Optimization feature. QuickOpt Timing Cycle Optimization can recommend the optimal A-V (atrial-ventricular) and/or V-V (ventricular-ventricular) timing values, depending upon device model, to use in programming the devices. Optimized timing can increase the efficiency of the heart’s ability to pump blood to the body. Traditional echocardiography, while considered the gold standard for optimizing devices, is expensive and time-consuming. QuickOpt Timing Cycle Optimization produces results clinically proven to be comparable with those of echo, in 90 seconds instead of the 30 to 120 minutes required for a typical echo. Additionally, the Accent RF pacemaker features the St. Jude Medical Ventricular Intrinsic Preference (VIP®) algorithm, with which the device monitors the heart beat-by-beat and provides pacing only when necessary. Allowing the patient’s natural heart rhythm to work on its own when possible has been shown to benefit overall heart health. The™ Patient Care Network version 4.0, which will support the Accent RF and Anthem RF remote monitoring capabilities, is expected to be approved by mid-summer. _____________________________

Boston Scientific Announces European Approval and First Implants of New Defibrillation Lead System Designed to Simplify the Surgical Process

Boston Scientific Corporation announced CE Mark and the first human implants of the company's ENDOTAK RELIANCE® 4-SITE defibrillation lead system. The ENDOTAK RELIANCE 4-SITE lead system is designed to simplify the implant procedure by combining three terminals into one integrated connector, reducing the required implant area within the body. This system, combined with the new TELIGEN® ICD and COGNIS® CRT-D, is designed to comply with the forthcoming international connector standard.1 The new standard will permit product compatibility across manufacturers. The company is working with physicians to launch the system in several phases with a focus on monitoring clinical performance through robust post-market analysis enhanced by the LATITUDE® Patient Management system.2 This technology allows these small and thin, high-energy ICDs and CRT-Ds to become even smaller. The connector reduces the volume of TELIGEN and COGNIS to 30 cc and 32 cc respectively, while maintaining a thickness of less than 10 mm. Some models of the ENDOTAK RELIANCE 4-SITE product line feature a proprietary GORE™ covering designed to prevent tissue ingrowth into the defibrillation coils, without compromising the electrical performance of the lead. The ENDOTAK RELIANCE G model is the only defibrillation lead on the market to address tissue ingrowth using this approach. Preventing tissue ingrowth assists physicians with the long-term management of device patients. Although rare, lead removal is sometimes necessary. Studies have shown that the proprietary covering helps physicians perform this procedure more easily and effectively. The implants were performed under the leadership of the following physicians: Oliver Przibille, MD, Cardioangiolisches Centrum Bethanien, Frankfurt, Germany; Hans-Joachim Trappe, MD, Marienhospital Herne Klinikum der Ruhr-Universitat Bochum, Herne, Germany; Johannes Heintze, MD, Herz und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen, Bad Oeynhausen, Germany; and Lieselot van Erven, MD, Leiden University Medical Center, Leiden, The Netherlands. 1 International Organization for Standardization (ISO) IS-4/DF-4 standard. 2 The LATITUDE Patient Management system is not yet approved in Europe. _____________________________

Medtronic Launches Clinical Trial to Improve Quality of Care for Implantable Defibrillator Patients

Medtronic, Inc. announced the launch of the Shock-Less clinical trial. This trial will identify ways physicians can improve the quality of care for patients through optimal application of device-based tools designed to reduce unnecessary shocks in patients with implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices. Specifically, the Shock-Less study aims to create evidence that will increase the use of programming tools that reduce unnecessary shocks including features on Medtronic devices, such as Medtronic’s exclusive Lead Integrity Alert™ (LIA) and Anti-Tachycardia Pacing (ATP) During Charging™. “Medtronic has pioneered the advances in shock reduction technology, supported by large randomized clinical trials, in the last several years; in fact, with current Medtronic programming and technology, frequency of shocks can be reduced by more than 63 percent,” said Marshall Stanton, MD, vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. While appropriate defibrillation therapy is proven to saves lives, unnecessary shocks can be reduced in several ways: • Using proprietary device programming for Medtronic’s Anti-Tachycardia Pacing (ATP) During Charging to deliver painless pacing pulses to safely and effectively terminate dangerous ventricular tachyarrhythmias; • Using Medtronic exclusives Wavelet™ SVT in single-chamber ICDs and Medtronic’s PR Logic® in dual-chamber ICDs to reduce shocks that may be delivered due to heart rhythms for which therapy is unnecessary (supraventricular tachycardias or non-sustained ventricular tachycardias); • Using the Medtronic exclusive Lead Integrity Alert, a continuous ICD monitoring technology that alerts clinicians and makes real-time device changes to reduce the potential of inappropriate therapy that may result from fractured leads; • Maximizing device programming detection and therapy parameters to reduce shocks for non-sustained arrhythmias in Medtronic devices with short and consistent charge times. “Despite the evidence, physicians are not maximizing the clinically proven programming tools to help reduce unnecessary shocks for their patients,” said Avi Fischer, MD, principal trial investigator and assistant professor of Medicine and director of Pacemaker and Defibrillator Therapy at Mount Sinai Medical Center in New York. “Our aim is to document the differences in the way these devices are programmed and understand the barriers to using this proven therapy. We hope to better understand how outcomes and patient management can be improved through shock reduction.” Physicians in the study will receive customized reports showing the reasons patients received shocks and analysis on how consistently their patient’s devices are programmed using the latest clinical evidence as compared to others in their region, and study-wide. Additionally, the trial is also designed to show how physicians change their device programming practices after shocks are delivered. Medtronic’s Shock-Less Trial is a prospective, quality improvement trial that will enroll approximately 2,500 subjects at approximately 125 U.S. and Canadian medical centers. Medtronic ICD and CRT-D patients will be followed in the study for at least two years. Data will be gathered from device downloads as well as through Medtronic CareLink® Network transmissions, a remote monitoring network that currently allows more than 350,000 Medtronic patients worldwide to send cardiac device information automatically to more than 3,000 clinics in 20 countries. Medtronic also will collect performance data on Medtronic’s proprietary shock reduction tool, Lead Integrity Alert™; LIA is the exclusive continuous ICD monitoring technology that offers at least three days advanced warning in three out of four defibrillator patients with lead fracture. It safely and automatically increases the number of intervals required to detect VF (following detection of a lead fracture) to avoid treating lead fractures as VF. LIA is available worldwide on Medtronic ICD and CRT-D devices. The latest LIA version for the newest portfolio of Vision 3D™ devices will be available in the U.S. in the coming months. Medtronic continues to provide the broadest portfolio of scientific research in the area of shock reduction, including: • ADVANCE III (Avoid Delivering Therapies for Non-Sustained Arrhythmias in ICD Patients III) is an ongoing trial to determine if Medtronic ’s Anti-Tachycardia Pacing (ATP) During Charging and extending the time to detect and treat arrhythmias safely, can reduce the necessity for shock therapy in all ICD-indicated patients. • ADVANCE CRT-D (ATP Delivery for Painless ICD Therapy in CRT-D) showed that ATP for fast ventricular tachycardias is safe and effective in CRT candidates, and patients with coronary artery disease benefit more from biventricular ATP. • ADVANCE-D (ATP Delivery for Painless ICD Therapy) is an ongoing trial comparing different ATP therapies to optimize success of painless therapies for ventricular tachyarrhythmias in patients with ICDs. • COMFORT (Concept of Optimal Management of Ventricular Fibrillation or Very Fast Ventricular Tachycardia) is evaluating the efficacy and safety of ATP and low-energy cardioversion for ventricular arrhythmias in patients with ICDs. • EMPIRIC (Comparison of Empiric to Physician-Tailored Programming of Implantable Cardioverter-Defibrillators) proved that now standardized Medtronic device settings are as safe and effective as individual, physician-tailored device settings to reduce shocks. • ENTRUST originally demonstrated the safety and efficacy of ATP During Charging, which delivers painless ATP therapy during capacitor charging and prevents delay of shock therapy when needed. • PainFREE Rx and PainFREE Rx II (Pacing Fast Ventricular Tachycardia Reduces Shock Therapies) showed that three out of four shocks are eliminated using ATP, thus improving quality of life. • PREPARE (Proven Shock Reduction for Primary Prevention Patients) showed a 63 percent reduction in unnecessary shocks for primary prevention patients. • GEM DR showed that Medtronic’s PR Logic® dual-chamber rhythm detection resulted in more accurate tachyarrhythmia therapy to help reduce inappropriate shocks. • RELEVANT (Registry on Left Ventricular Dysfunction and Non-ischemic Ventricular Tachyarrhythmias) showed that extending the time an ICD takes to detect and treat arrhythmias is safe and effective in reducing shocks for non-ischemic primary prevention heart failure patients. • WAVE (Worldwide Application of Marquis VR Enhancements) showed that the Medtronic exclusive Wavelet™ SVT discrimination feature in single-chamber ICDs reduced inappropriate therapy by 78 percent. • SATISFACTION (Survey on Antitachycardia Pacing Strategy for the Termination of Fast Ventricular Tachycardia in Japanese Implantable Cardioverter-Defibrillator Population) will determine the efficacy of ATP to painlessly terminate ventricular tachycardias in Japanese ICD and CRT-D patients.